The Influence of Surgical Complexity and Center Experience on Postoperative Morbidity After Minimally Invasive Surgery in Gynecologic Oncology: Lessons Learned from the ROBOGYN-1004 Trial.

BACKGROUND: This study was a secondary analysis of the ROBOGYN-1004 trial conducted between 2010 and 2015. The study aimed to identify factors that affect postoperative morbidity after either robot-assisted laparoscopy (RL) or conventional laparoscopy (CL) in gynecologic oncology. METHODS: The study used two-level logistic regression analyses to evaluate the prognostic and predictive value of patient, surgery, and center characteristics in predicting severe postoperative morbidity 6 months after surgery. RESULTS: This analysis included 368 patients. Severe morbidity occurred in 49 (28 %) of 176 patients who underwent RL versus 41 (21 %) of 192 patients who underwent CL (p = 0.15). In the multivariate analysis, after adjustment for the treatment group (RL vs CL), the risk of severe morbidity increased significantly for patients who had poorer performance status, with an odds ratio (OR) of 1.62 for the 1-point difference in the WHO performance score (95 % CI 1.06-2.47; p = 0.027) and according to the type of surgery (p < 0.001). A focus on complex surgical acts showed significant more morbidity in the RL group than in the CL group at the less experienced centers (OR, 3.31; 95 % CI 1.0-11; p = 0.05) compared with no impact at the experienced centers (OR, 0.87; 95 % CI 0.38-1.99; p = 0.75). CONCLUSION: The findings suggest that the center's experience may have an impact on the risk of morbidity for patients undergoing complex robot-assisted surgical procedures.

Validation of the Safety and Efficacy of Apixaban as Postoperative Thromboembolism Prophylaxis for Patients with Gynecologic Malignancies.

BACKGROUND: Venous thromboembolism is a preventable complication of gynecologic cancer surgery that leads to postoperative morbidity and mortality. This study compared apixaban with enoxaparin to identify whether apixaban had the same safety and efficacy for patients undergoing gynecologic cancer surgery. METHODS: The study identified patients with a gynecologic malignancy who underwent surgery and were prescribed apixaban at discharge between June 2020 and April 2023. International Classification of Diseases 10 codes were used to identify patients who had a thromboembolism within 90 days or a bleeding event within 60 days after surgery. The rates of events for patients prescribed apixaban were compared with those for a historical cohort of patients who received enoxaparin. Fisher's exact tests were used to compare categorical variables, and t tests were used to compare continuous variables. A logistic regression was performed to compare the odds of thromboembolism between the two groups. RESULTS: Baseline patient characteristics differed in terms of body mass index (BMI), race, route of surgery, and type of cancer. Of the 490 patients in the apixaban cohort, 12 (2.4%) had a thromboembolism compared with 3 (2.1%) of the 138 patients in the enoxaparin group (adjusted odds ratio [aOR], 1.02; 95% confidence interval [CI] 0.30-4.70; p > 0.999). The odds ratio was adjusted for BMI, age, and route of surgery. A bleeding event occurred for 1 (0.2%) of the 490 patients in the apixaban group and for 1 (0.7%) of the 138 patients in the enoxaparin group. CONCLUSIONS: This validation study showed that apixaban is a safe and effective method of postoperative venous thromboembolism prophylaxis. The data provide support to previous data and guideline updates recommending the use of apixaban for postoperative prophylaxis.

The activity advantage: Objective measurement of preoperative activity is associated with postoperative recovery and outcomes in patients undergoing surgery with gynecologic oncologists.

OBJECTIVE: To examine the association between objectively-measured preoperative physical activity with postoperative outcomes and recovery milestones in patients undergoing gynecologic oncology surgeries. METHODS: Prospective cohort study of patients undergoing surgery with gynecologic oncologists who wore wearable actigraphy rings before and after surgery from 03/2021-11/2023. Exposures encompassed preoperative activity intensity (moderate- and vigorous-intensity metabolic equivalent of task-minutes [MAVI MET-mins] over seven days) and level (average daily steps over seven days). Intensity was categorized as <500, 500-1000, and >1000 MAVI MET-mins; level categorized as <8000 and ≥8000 steps/day. Primary outcome was 30-day complications. Secondary outcomes included reaching postoperative goal (≥70% of recommended preoperative intensity and level thresholds) and return to baseline (≥70% of individual preoperative intensity and level). RESULTS: Among 96 enrolled, 87 met inclusion criteria, which constituted 39% (n = 34) with <500 MET-mins and 56.3% (n = 49) with <8000 steps preoperatively. Those with <500 MET-mins and <8000 steps had higher ECOG scores (p = 0.042 & 0.037) and BMI (p = 0.049 & 0.002) vs those with higher activity; all other perioperative characteristics were similar between groups. Overall, 29.9% experienced a 30-day complication, 29.9% reached postoperative goal, and 64.4% returned to baseline. On multivariable models, higher activity was associated with lower odds of complications: 500-1000 MET-mins (OR = 0.26,95%CI = 0.07-0.92) and >1000 MET-mins (OR = 0.25,95%CI = 0.07-0.94) vs <500 MET-mins; ≥8000 steps (OR = 0.25,95%CI = 0.08-0.73) vs <8000 steps. Higher preoperative activity was associated fewer days to reach postoperative goal. CONCLUSION: Patients with high preoperative activity are associated with fewer postoperative complications and faster attainment of recovery milestones. Physical activity may be considered a modifiable risk factor for adverse postoperative outcomes.

A multi-center study to predict the risk of intraoperative hypothermia in gynecological surgery patients using preoperative variables.

OBJECTIVES: Hypothermia is highly common in patients undergoing gynecological surgeries under general anesthesia, so the length of hospitalization and even the risk of mortality are substantially increased. Our aim was to develop a simple and practical model to preoperatively identify gynecological surgery patients at risk of intraoperative hypothermia. METHODS: In this retrospective study, we collected data from 802 patients who underwent gynecological surgery at three medical centers from June 2022 to August 2023. We further allocated the patients to a training group, an internal validation group, or an external validation group. The preliminary predictive factors for intraoperative hypothermia in gynecological patients were determined using the least absolute shrinkage and selection operator (LASSO) method. The final predictive factors were subsequently identified through multivariate logistic regression analysis, and a nomogram for predicting the occurrence of hypothermia was established. RESULTS: A total of 802 patients were included, with 314 patients in the training cohort (mean age 48.5 ± 12.6 years), 130 patients in the internal validation cohort (mean age 49.9 ± 12.5 years), and 358 patients in the external validation cohort (mean age 47.6 ± 14.0 years). LASSO regression and multivariate logistic regression analyses indicated that body mass index, minimally invasive surgery, baseline heart rate, baseline body temperature, history of previous surgery, and aspartate aminotransferase level were associated with intraoperative hypothermia in gynecological surgery patients. This nomogram was constructed based on these six variables, with a C-index of 0.712 for the training cohort. CONCLUSIONS: We established a practical predictive model that can be used to preoperatively predict the occurrence of hypothermia in gynecological surgery patients. CLINICAL TRIAL REGISTRATION: chictr.org.cn, identifier ChiCTR2300071859.

Implementation of a surgical site infection prevention bundle in gynecologic oncology patients: An enhanced recovery after surgery initiative.

OBJECTIVE: To evaluate the clinical outcomes pre- and post-implementation of an evidence-informed surgical site infection prevention bundle (SSIPB) in gynecologic oncology patients within an Enhanced Recovery After Surgery (ERAS) care pathway. METHODS: Patients undergoing laparotomy for a gynecologic oncology surgery between January-June 2017 (pre-SSIPB) and between January 2018-December 2020 (post-SSIPB) were compared using t-tests and chi-square. Patient characteristics, surgical factors, and ERAS process measures and outcomes were abstracted from the ERAS® Interactive Audit System (EIAS). The primary outcomes were incidence of surgical site infections (SSI) during post-operative hospital admission and at 30-days post-surgery. Secondary outcomes included total postoperative infections, length of stay, and any surgical complications. Multivariate models were used to adjust for potential confounding factors. RESULTS: Patient and surgical characteristics were similar in the pre- and post-implementation periods. Evaluation of implementation suggested that preoperative and intraoperative components of the intervention were most consistently used. Infectious complications within 30 days of surgery decreased from 42.1% to 24.4% after implementation of the SSIPB (p < 0.001), including reductions in wound infections (17.0% to 10.8%, p = 0.02), urinary tract infections (UTI) (12.7% to 4.5%, p < 0.001), and intra-abdominal abscesses (5.4% to 2.5%, p = 0.05). These reductions were associated with a decrease in median length of stay from 3 to 2 days (p = 0.001). In multivariate analysis, these SSI reductions remained statistically significant after adjustment for potential confounders. CONCLUSION: Implementation of SSIPB was associated with a reduction in SSIs and infectious complications, as well as a shorter length of stay in gynecologic oncology patients.

Impact of pharmacogenomic profiles on post-surgical pain following laparotomy for gynecologic pathology.

OBJECTIVES: The aim of this prospective study was to compare perioperative opioid use in women by status of CYP2D6, a highly polymorphic pharmacogene relevant to opioid metabolism. METHODS: Patients undergoing laparotomy were prospectively recruited and provided a preoperative saliva swab for a pharmacogenomic (PGx) gene panel. Postoperative opioid usage and pain scores were evaluated via chart review and a phone survey. Pharmacogenes known to be relevant to opioid metabolism were genotyped, and opioid metabolizing activity predicted by CYP2D6 genotyping. Patient and procedural factors were compared using Fisher's exact and Kruskal-Wallis tests. RESULTS: The 96 enrolled patients were classified as ultra-rapid (N = 3, 3%), normal (58, 60%), intermediate (27, 28%), and poor (8, 8%) opioid metabolizers. There was no difference in surgical complexity across CYP2D6 categories (p = 0.61). Morphine Milligram Equivalents (MME) consumed during the first 24 h after peri-operative suite exit were significantly different between groups: ultrarapid metabolizers had the highest median MME (75, IQR 45-88) compared to the other three groups (normal metabolizers 23 [8-45], intermediate metabolizers 48 [20-63], poor metabolizers 31 [12-53], p = 0.03). Opioid requirements were clinically greater in ultrarapid metabolizers during the second 24 h and last 24 h but were statistically similar (p = 0.07). There was no difference in MME prescribed at discharge (p = 0.22) or patient satisfaction with pain control (p = 0.64) between groups. CONCLUSIONS: A positive association existed between increased CYP2D6 activity and in-hospital opioid requirements, especially in the first 24 h after surgery. This provides important information to further individualize opioid prescriptions for patients undergoing laparotomy for gynecologic pathology.

Efficacy, safety, and feasibility of Apixaban for postoperative venous thromboembolism prophylaxis following open gynecologic cancer surgery at a comprehensive cancer center.

OBJECTIVES: To evaluate safety, efficacy, and feasibility of apixaban for postoperative venous thromboembolism (VTE) prophylaxis following open gynecologic cancer surgery at a comprehensive cancer center. METHODS: This retrospective, cohort study included patients with gynecologic cancer who underwent open surgery between 3/2021 and 3/2023 and received 28-day postoperative VTE prophylaxis. Patients on therapeutic anticoagulation preoperatively were excluded. Predictors of 90- and 30-day VTE and 30-day bleeding events were determined using multivariable logistic regression, adjusting for known confounders. RESULTS: 452 patients were included in the cohort: 348 received apixaban and 104 received enoxaparin. Those who received enoxaparin were more likely to be American Society of Anesthesiologists class III/IV (compared to I/II) (p = 0.033), current or former smokers (p = 0.012) and have a higher BMI (p < 0.001), Charlson Comorbidity Index (p = 0.005), and age (p = 0.046). 30-day VTE rate was significantly lower in the apixaban group (0.6%) compared to the enoxaparin group (6.2%) (adjusted OR 0.13, 95% CI 0.03-0.56; p = 0.006). 90-day VTE rate was 2.7% and 6.2% in the apixaban and enoxaparin groups, respectively (adjusted OR 0.85, 95% CI 0.38-1.92; p = 0.704). Major bleeding complications (2.4% vs. 2.0%) and minor bleeding complications (0.9% vs. 3.0%) were similar in the apixaban and enoxaparin groups, respectively, on multivariate analyses. The median patient out of pocket cost was $10 (IQR 0.0-40.0) for apixaban and $20 (IQR 3.7-67.7) for enoxaparin (p = 0.001). CONCLUSIONS: Our findings along with previously published data suggest that apixaban should be considered the standard of care for VTE prophylaxis in patients undergoing open surgery for gynecologic malignancies.

Avoiding the needle: A quality improvement program introducing apixaban for extended thromboprophylaxis after major gynecologic cancer surgery.

OBJECTIVE: Patients undergoing gynecologic cancer surgery at our centre are recommended up to 28 days of enoxaparin for extended post-operative thromboprophylaxis (EP). Baseline survey revealed 92% patient adherence, but highlighted negative effects on patient experience due to the injectable route of administration. We aimed to improve patient experience by reducing pain and bruising by 50%, increasing adherence by 5%, and reducing out-of-pocket cost after introducing apixaban as an oral alternative for EP. METHODS: In this interrupted time series quality improvement study, gynecologic cancer patients were offered a choice between apixaban (2.5 mg orally twice daily) or enoxaparin (40 mg subcutaneously once daily) at time of discharge. A multidisciplinary team informed project design, implementation, and evaluation. Process interventions included standardized orders, patient and care team education programs. Telephone survey at 1 and 6 weeks and chart audit informed outcome, process, and balancing measures. RESULTS: From August to October 2022, 127 consecutive patients were included. Apixaban was chosen by 84%. Survey response rate was 74%. Patients who chose apixaban reported significantly reduced pain, bruising, increased confidence with administration, and less negative impact of the medication (p < 0.0001 for all). Adherence was unchanged (92%). The proportion of patients paying less than $125 (apixaban cost threshold) increased from 45% to 91%. There was no difference in bleeding and no VTE events. CONCLUSIONS: Introduction of apixaban for EP was associated with significant improvement in patient-reported quality measures and reduced financial toxicity with no effect on adherence or balancing measures. Apixaban is the preferred anticoagulant for EP at our centre.

Risk of thrombosis and bleeding in gynecologic noncancer surgery: systematic review and meta-analysis.

OBJECTIVE: This study aimed to provide procedure-specific estimates of the risk for symptomatic venous thromboembolism and major bleeding in noncancer gynecologic surgeries. DATA SOURCES: We conducted comprehensive searches on Embase, MEDLINE, Web of Science, and Google Scholar. Furthermore, we performed separate searches for randomized trials that addressed the effects of thromboprophylaxis. STUDY ELIGIBILITY CRITERIA: Eligible studies were observational studies that enrolled ≥50 adult patients who underwent noncancer gynecologic surgery procedures and that reported the absolute incidence of at least 1 of the following: symptomatic pulmonary embolism, symptomatic deep vein thrombosis, symptomatic venous thromboembolism, bleeding that required reintervention (including re-exploration and angioembolization), bleeding that led to transfusion, or postoperative hemoglobin level <70 g/L. METHODS: A teams of 2 reviewers independently assessed eligibility, performed data extraction, and evaluated the risk of bias of the eligible articles. We adjusted the reported estimates for thromboprophylaxis and length of follow-up and used the median value from studies to determine the cumulative incidence at 4 weeks postsurgery stratified by patient venous thromboembolism risk factors and used the Grading of Recommendations Assessment, Development and Evaluation approach to rate the evidence certainty. RESULTS: We included 131 studies (1,741,519 patients) that reported venous thromboembolism risk estimates for 50 gynecologic noncancer procedures and bleeding requiring reintervention estimates for 35 procedures. The evidence certainty was generally moderate or low for venous thromboembolism and low or very low for bleeding requiring reintervention. The risk for symptomatic venous thromboembolism varied from a median of <0.1% for several procedures (eg, transvaginal oocyte retrieval) to 1.5% for others (eg, minimally invasive sacrocolpopexy with hysterectomy, 1.2%-4.6% across patient venous thromboembolism risk groups). Venous thromboembolism risk was <0.5% for 30 (60%) of the procedures; 0.5% to 1.0% for 10 (20%) procedures; and >1.0% for 10 (20%) procedures. The risk for bleeding the require reintervention varied from <0.1% (transvaginal oocyte retrieval) to 4.0% (open myomectomy). The bleeding requiring reintervention risk was <0.5% in 17 (49%) procedures, 0.5% to 1.0% for 12 (34%) procedures, and >1.0% in 6 (17%) procedures. CONCLUSION: The risk for venous thromboembolism in gynecologic noncancer surgery varied between procedures and patients. Venous thromboembolism risks exceeded the bleeding risks only among selected patients and procedures. Although most of the evidence is of low certainty, the results nevertheless provide a compelling rationale for restricting pharmacologic thromboprophylaxis to a minority of patients who undergo gynecologic noncancer procedures.

Patient perspectives in adverse event reporting after vaginal apical prolapse surgery.

BACKGROUND: Many clinical trials use systematic methodology to monitor adverse events and determine grade (severity), expectedness, and relatedness to treatments as determined by clinicians. However, patient perspectives are often not included in this process. OBJECTIVE: This study aimed to compare clinician vs patient grading of adverse event severity in a urogynecologic surgical trial. Secondary objectives were to estimate the association of patient grading of adverse events with decision-making and quality of life outcomes and to determine if patient perspective changes over time. STUDY DESIGN: This was a planned supplementary study (Patient Perspectives in Adverse Event Reporting [PPAR]) to a randomized trial comparing 3 surgical approaches to vaginal apical prolapse. In the parent trial, adverse events experienced by patients were collected per a standardized protocol every 6 months during which clinicians graded adverse event severity (mild, moderate, severe/life-threatening). In this substudy, we obtained additional longitudinal patient perspectives for 19 predetermined "PPAR adverse events." Patients provided their own severity grading (mild, moderate, severe/very severe/life-threatening) at initial assessment and at 12 and 36 months postoperatively. Clinicians and patients were masked to each other's reporting. The primary outcome was the interrater agreement (kappa statistic) for adverse event severity between the initial clinician and patient assessment, combining patient grades of mild and moderate. The association between adverse event severity and the Decision Regret Scale, Satisfaction with Decision Scale, the 12-Item Short-Form Health Survey, and Patient Global Impression of Improvement scores was assessed using the Spearman correlation coefficient (ρ) for continuous scales, the Mantel-Haenszel chi-square test for Patient Global Impression of Improvement, and t tests or chi-square tests comparing the assessments of patients who rated their adverse events or symptoms as severe with those who gave other ratings. To describe patient perspective changes over time, the intraobserver agreement was estimated for adverse event severity grade over time using weighted kappa coefficients. RESULTS: Of the 360 randomly assigned patients, 219 (61%) experienced a total of 527 PPAR adverse events (91% moderate and 9% severe/life-threatening by clinician grading). Mean patient age was 67 years; 87% were White and 12% Hispanic. Among the patients reporting any PPAR event, the most common were urinary tract infection (61%), de novo urgency urinary incontinence (35%), stress urinary incontinence (22%), and fecal incontinence (13%). Overall agreement between clinician and participant grading of severity was poor (kappa=0.24 [95% confidence interval, 0.14-0.34]). Of the 414 adverse events that clinicians graded as moderate, patients graded 120 (29%) as mild and 80 (19%) as severe. Of the 39 adverse events graded as severe by clinicians, patients graded 15 (38%) as mild or moderate. Initial patient grading of the most severe reported adverse event was mildly correlated with worse Decision Regret Scale (ρ=0.2; P=.01), 12-Item Short-Form Health Survey (ρ=-0.24; P<.01), and Patient Global Impression of Improvement (P<.01) scores. There was no association between adverse event severity and Satisfaction with Decision Scale score. Patients with an initial grading of "severe" had more regret, lower quality of life, and poorer global impressions of health than those whose worst severity grade was mild (P<.05). Agreement between the patients' initial severity ratings and their ratings at 12 months (kappa=0.48 [95% confidence interval, 0.39-0.58]) and 36 months (kappa=0.45 [95% confidence interval, 0.37-0.53]) was fair. CONCLUSION: Clinician and patient perceptions of adverse event severity are discordant. Worse severity from the patient perspective was associated with patient-centered outcomes. Including the patient perspective provides additional information for evaluating surgical procedures.

Metronidazole and cefazolin vs cefazolin alone for surgical site infection prophylaxis in gynecologic surgery at a comprehensive cancer center.

BACKGROUND: Surgical site infection is one of the most common complications of gynecologic cancer surgery. Current guidelines recommend the administration of cefazolin preoperatively to reduce surgical site infection rates for patients undergoing clean-contaminated surgeries such as hysterectomy. OBJECTIVE: To evaluate the impact of a quality improvement project adding metronidazole to cefazolin for antibiotic prophylaxis on surgical site infection rate for women undergoing gynecologic surgery at a comprehensive cancer center. STUDY DESIGN: This retrospective, single-center cohort study included patients who underwent surgery in the gynecologic oncology department from May 2017 to June 2023. Patients with penicillin allergies and those undergoing concomitant bowel resections and/or joint cases were excluded. The preintervention group patients had surgery from May 2017 to April 2022, and the postintervention group patients had surgery from April 2022 to June 2023. The primary outcome was a 30-day surgical site infection rate. Sensitivity analyses were performed to compare surgical site infection rates on the basis of actual antibiotics received and for those who had a hysterectomy. Factors independently associated with surgical site infection were identified using a multivariable logistic regression model adjusting for confounding variables. RESULTS: Of 3343 patients, 2572 (76.9%) and 771 (23.1%) were in the pre-post intervention groups, respectively. Most patients (74.7%) had a hysterectomy performed. Thirty-four percent of cases were for nononcologic (benign) indications. Preintervention patients were more likely to receive appropriate preoperative antibiotics (95.6% vs 90.7%; P<.001). The overall surgical site infection rate before the intervention was 4.7% compared with 2.6% after (P=.010). The surgical site infection rate for all patients who underwent hysterectomy was 4.9% (preintervention) vs 2.8% (postintervention) (P=.036); a similar trend was seen for benign cases (4.4% vs 2.4%; P=.159). On multivariable analysis, the odds ratio for surgical site infection was 0.49 (95% confidence interval, 0.38-0.63) for the postintervention compared with the preintervention group (P<.001). In a sensitivity analysis (n=3087), the surgical site infection rate was 4.5% for those who received cefazolin alone compared with 2.3% for those who received cefazolin plus metronidazole, with significantly decreased odds of surgical site infection for the cefazolin plus metronidazole group (adjusted odds ratio, 0.40 [95% confidence interval, 0.30-0.53]; P<.001). Among only those who had a hysterectomy performed, the odds of surgical site infection were significantly reduced for those in the postintervention group (adjusted odds ratio, 0.63 [95% confidence interval, 0.47-0.86]; P=.003). CONCLUSION: The addition of metronidazole to cefazolin before gynecologic surgery decreased the surgical site infection rate by half, even after accounting for other known predictors of surgical site infection and differences in practice patterns over time. Providers should consider this combination regimen in women undergoing gynecologic surgery, especially for cases involving hysterectomy.

Prophylactic ureteric catheterisation during complex gynaecological surgery: A systematic review and meta-analysis.

BACKGROUND: There is a lack of robust evidence to recommend the use of perioperative ureteric catheterisation or stenting in complex gynaecological surgery. OBJECTIVES: To evaluate the evidence on the benefits and risks of perioperative ureteric catheterisation or stenting in complex gynaecological surgery. SEARCH STRATEGY: A literature search was performed in CINAHL, the Cochrane Library, Embase and MEDLINE, from 1946 to January 2024, using a combination of keywords and Medical Subject Headings (MeSH) terminology. SELECTION CRITERIA: Randomised controlled trials (RCTs) and observational studies were included. DATA COLLECTION AND ANALYSIS: Meta-analysis of the RCTs and observational studies were performed separately. Cochrane RevMan 6.5.1 was used to undertake meta-analysis. Risk ratios with 95% CIs were calculated for the outcome measures. MAIN RESULTS: Ten studies were included: three RCTs and seven observational studies, comprising 8661 patients. The three RCTs, comprising a total of 3277 patients, showed no difference in the risk of immediate complications in the form of ureteric injury between the ureteric stent and the control groups (RR 0.9, 95% CI 0.49-1.65). The observational studies included 5384 patients. Four studies that explored the ureteric injury as an outcome did not show any difference between the two groups (RR 0.76, 95% CI 0.27-2.16). One case-control study with 862 participants found that the rate of ureteric injury was higher in the non-stented group, although this was observed in only three patients. The risk of urinary tract infection (UTI) was increased in the stent group, although not with statistical significance (RR 1.84, 95% CI 0.47-7.17). There was no significant difference in the risk of ureteric fistulae (RR 1.91, 95% CI 0.62-5.83), although the number of studies was limited. CONCLUSIONS: Prophylactic ureteric catheterisation or stenting for complex gynaecological surgery is not associated with a lower risk of ureteric injury.

Complications of obliterative versus reconstructive vaginal surgery for pelvic organ prolapse in octogenarians: A retrospective cohort study.

AIMS: Women of advanced age may choose between restorative or obliterative surgery for surgical management of pelvic organ prolapse. Obliterative surgery is traditionally reserved for a subset of older women with more severe medical comorbidities, since obliterative approaches are generally considered to be less morbid and older individuals have higher rates of perioperative complications than younger cohorts. This study compared perioperative complications amongst octogenarians undergoing obliterative versus reconstructive approaches. This data will help to inform perioperative counselling as previous studies have not been powered to evaluate complications in this population. METHODS: The National Surgical Quality Improvement Program database was used to identify patients that had Pelvic organ prolapse surgery between 2012 and 2021, aged 80 years or older. Single-compartment procedures, vaginal mesh procedures, and oncologic surgery were excluded. The primary outcome was any complication within the first 30 days excluding urinary tract infection (UTI). UTI, readmission, and severe complications were secondary outcomes. RESULTS: Of the 4149 patients identified, 2514 (60.6%) underwent reconstructive surgery and 1635 (39.4%) underwent obliterative surgery. Patients undergoing reconstructive surgery were more likely to have an American Society of Anesthesiologists (ASA) class of 1 or 2 (46.1% vs. 31.3%, p = 0.002) and were less likely to be on antihypertensive medication (72.0% vs. 75.8%, p = 0.006). Further, there was an increased length of stay (1.47 ± 1.84 vs. 1.03 ± 1.31 days, p < 0.001) in hospital for reconstructive surgery which was more often performed as an inpatient (45.7% vs. 37.9%, p < 0.001). There was no difference in the primary outcome: any complication excluding UTIs. However, UTI was more common in the reconstructive group (aOR 0.48; 95% confidence interval 0.34-0.0). The rate of serious complications (Clavien-Dindo Class IV) was low overall and not different between reconstructive and obliterative approaches (1.3% vs. 1.0%, respectively). CONCLUSIONS: Both vaginal reconstructive and obliterative approaches have low complication rates in octogenarians, with only UTI rate being different between cohorts. When choosing surgical approach, we suggest a case-based, patient center discussion on the anatomic outcomes, durability and patient satisfaction.

Fine-tuning the needle: analysis of acupuncturist response to alarming events during gynecological oncology surgery.

OBJECTIVE: Examining an intra-operative acupuncture/acupressure setting, with real-time "fine-tuning" in response to alarming events (AEvs) during gynecological oncology surgery. METHODS: Narratives of acupuncturists providing intraoperative acupuncture during gynecological oncology surgery were qualitatively analyzed. These described real time "fine-tuning" in response to AEvs during surgery, identified through hemodynamic changes (e.g., systolic/diastolic arterial pressure); bispectral index (BIS) elevation; and feedback from surgeons and anesthesiologists. Documentation of acupuncturist responses to AEvs was addressed as well. RESULTS: Of the 48 patients in the cohort, 33 had at least one intraoperative AEv (69%), of which 30 were undergoing laparoscopic surgery and 18 laparotomies. A total of 77 AEvs were documented throughout surgery (range 1-7; mean: 2.3 events per patient), identified through increased (63 events) or decreased (8) mean arterial pressure (MAP); increased BIS levels (2), or other hemodynamic parameters (4). Integrative oncology interventions implemented in response to AEs included acupressure alone (59); combining acupressure with acupuncture (10); or acupuncture alone (4). In 54 (70%) events, documentation was provided from beginning to conclusion of the AEv, with a mean duration of 9.7 min, with 32 events including a documented anesthesiologist intervention. CONCLUSION: The present study demonstrated the feasibility of intraoperative acupuncture with acupressure, with ongoing "fine-tuning" to AEvs identified through objective pain-related parameters (MAP, heart rate and BIS) and real-time input from surgeons and anesthesiologists. Documentation of the intraoperative IO practitioner's response to these AEvs is important, and should be addressed in future research of the innovative integrative model of care. TRIAL REGISTRATION NUMBER: CMC-18-0037 (Carmel Medical Center, June 11, 2018).

Low serum creatinine levels are associated with major post-operative complications in patients undergoing surgery with gynecologic oncologists.

OBJECTIVE: Serum creatinine is a byproduct of muscle metabolism, and low creatinine is postulated to be associated with diminished muscle mass. This study examined the association between low pre-operative serum creatinine and post-operative outcomes. METHODS: This retrospective cohort study utilized the 2014-2021 National Surgical Quality Improvement Program to identify patients undergoing surgery with gynecologic oncologists. Patients with missing pre-operative creatinine, end-stage renal disease, sepsis, septic shock, dialysis, or pregnancy were excluded. Pre-operative creatinine was categorized into markedly low (≤0.44 mg/dL), mildly low (0.45-0.64 mg/dL), normal (0.65-0.84 mg/dL), and four categories of elevated levels (0.85-1.04, 1.05-1.24, 1.25-1.44, and ≥1.45 mg/dL). Outcomes included major (≥Grade 3) 30-day complications, categorized into any complications, wound, cardiovascular and pulmonary, renal, infectious, and thromboembolic complications. Also examined were 30-day readmissions, reoperations, and mortality. Logistic regressions assessed the association between creatinine and complications, with stratification by albumin and sensitivity analysis with propensity score matching. RESULTS: Among 84 786 patients, 0.8% had markedly low, 19.6% mildly low, and 50.2% normal creatinine; the remainder had elevated creatinine. As creatinine decreased, the risks of major complications increased in a dose-dependent manner on univariable and multivariable analyses. A total of 9.6% (n=63) markedly low patients experienced major complications, second to creatinine ≥1.45 mg/dL (9.9%, n=141). On multivariable models, both markedly and mildly low creatinine were associated with higher odds of major complications (OR 1.715, 95% CI 1.299 to 2.264 and OR 1.093, 95% CI 1.001 to 1.193) and infections (OR 1.575, 95% CI 1.118 to 2.218 and OR 1.165, 95% CI 1.048 to 1.296) versus normal. Markedly low creatinine had similar ORs to creatinine ≥1.45 mg/dL and was further associated with higher odds of cardiovascular and pulmonary complications (OR 2.301, 95% CI 1.300 to 4.071), readmissions (OR 1.403, 95% CI 1.045 to 1.884), and mortality (OR 2.718, 95% CI 1.050 to 7.031). After albumin stratification, associations persisted for markedly low creatinine. Propensity-weighted analyses demonstrated congruent findings. CONCLUSIONS: Low creatinine levels are associated with major post-operative complications in gynecologic oncology in a dose-dependent manner. Low creatinine can offer useful information for pre-operative risk stratification, surgical counseling, and peri-operative management.

Surgical site infection prevention bundle in gynecology oncology surgery: a key element in the implementation of an enhanced recovery after surgery (ERAS) program.

Surgical site infection rates are among 5-35% in all gynecologic oncology procedures. Such infections lead to increased patient morbidity, reduction in quality of life, higher likelihood of readmissions, and reinterventions, which contribute directly to mortality and increase in health-related costs. Some of these are potentially preventable by applying evidence-based strategies in the peri-operative patient setting. The objective of this review is to provide recommendations for the individual components that most commonly comprise the surgical site infection prevention bundles that could be implemented in gynecologic oncology procedures. We searched articles from relevant publications with specific topics related to each surgical site infection intervention chosen to be reviewed. Studies on each topic were selected with an emphasis on meta-analyses, systematic reviews, randomized control studies, non-randomized controlled studies, reviews, clinical practice guidelines, and case series. Data synthesis was done through content and thematic analysis to identify key themes in the included studies. This review intends to serve as the most up-to-date frame of evidence-based peri-operative care in our specialty and could serve as the first initiative to introduce an enhanced recovery after surgery (ERAS) program.

Precision in Practice: The Critical Role of Mesh and Procedure Type Specification in Urogynecological Surgeries and Research.

Recently, the debate surrounding the use of mesh in urogynecological procedures has intensified, leading to FDA warnings and heightened safety concerns. This clinical opinion emphasizes the vital need to specify mesh types in these procedures, drawing attention to the risk profiles and clinical outcomes associated with various meshes and the procedures that utilize them. A significant issue identified in contemporary literature is the tendency to group diverse mesh types under the same umbrella, disregarding their unique characteristics and applications. We describe the range of mesh types, their application routes, and associated complications, highlighting the risks of this nonspecific approach to patient safety and informed decision making. We critically examine the generalization of mesh terminology in clinical and research dialogues. Concluding with specific recommendations for health care providers and researchers, the paper advocates for a more nuanced understanding and communication in the field, ultimately aiming to improve patient care and safety in urogynecological practice.

Prediction of Postoperative Urinary Tract Infection Following Benign Gynecologic Surgery.

INTRODUCTION AND HYPOTHESIS: The objective was to develop a prediction model for urinary tract infection (UTI) after pelvic surgery. METHODS: We utilized data from three tertiary care centers of women undergoing pelvic surgery. The primary outcome was a UTI within 8 weeks of surgery. Additional variables collected included procedural data, severity of prolapse, use of mesh, anti-incontinence surgery, EBL, diabetes, steroid use, estrogen use, postoperative catheter use, PVR, history of recurrent UTI, operative time, comorbidities, and postoperative morbidity including venous thromboembolism, surgical site infection. Two datasets were used for internal validation, whereas a third dataset was used for external validation. Algorithms that tested included the following: multivariable logistic regression, decision trees (DTs), naive Bayes (NB), random forest (RF), gradient boosting (GB), and multilayer perceptron (MP). RESULTS: For the training dataset, containing both University of British Columbia and Mayo Clinic Rochester data, there were 1,657 patients, with 172 (10.4%) UTIs; whereas for the University of Calgary external validation data, there were a total of 392 patients with a UTI rate of 16.1% (n = 63). All models performed well; however, the GB, DT, and RF models all had an area under the curve (AUC) > 0.97. With external validation the model retained high discriminatory ability, DT: AUC = 0.88, RF: AUC = 0.88, and GB: AUC = 0.90. CONCLUSIONS: A model with high discriminatory ability can predict UTI within 8 weeks of pelvic surgery. Future studies should focus on prospective validation and application of randomized trial models to test the utility of this model in the prevention of postoperative UTI.

Perioperative Morbidity Associated with Same-day Discharge in Elderly Patients.

INTRODUCTION AND HYPOTHESIS: We compared postoperative complications in elderly patients discharged on POD#0 versus POD#1 after prolapse repair. METHODS: Data were obtained from the National Surgical Quality Improvement database. A total of 20,984 women 65 years and older who underwent prolapse repair between 2014 and 2020 were analyzed. Patient demographics, comorbidities, readmission, reoperation, and 30-day postoperative complications were compared in patients discharged on POD#0 versus POD#1. A sensitivity analysis was completed to examine outcomes in patients who underwent an apical prolapse repair. Multivariate logistic regression was performed to evaluate for potential confounders. RESULTS: Age, race, ethnicity, American Society of Anesthesiologists class, prolapse repair type, and operative time were significantly different in patients discharged on POD#0 vs POD#1 (all p < 0.01). Patients discharged on POD#0 had significantly fewer postoperative complications (2.63% vs 3.44%) and readmissions (1.56% vs 2.18%, all p < 0.01). On multivariate regression modeling, postoperative discharge day was independently associated with complications, but not with readmissions or reoperation after. Patients who underwent an apical prolapse repair and were discharged on POD#0 had significantly more postoperative complications (3.5% vs 2.5%, p = 0.02) and readmissions (2.42% vs 10.08%, p < 0.01) than those discharged on POD#1. In this group, multivariate regression modeling demonstrated that postoperative discharge day was independently associated with any postoperative complication. CONCLUSIONS: For elderly women undergoing prolapse repair, the type of surgery should be considered when determining postoperative admission versus same-day discharge. Admission overnight does not seem to benefit women undergoing vaginal repairs but may decrease overall morbidity and risk of readmission in women undergoing an apical prolapse repair.

Long-Term Mesh Exposure 5 Years Following Minimally Invasive Total Hysterectomy and Sacrocolpopexy.

INTRODUCTION AND HYPOTHESIS: The objective was to assess long-term mesh complications following total hysterectomy and sacrocolpopexy. METHODS: In this second extension study, women from a multicenter randomized trial were followed for more than 36 months after surgery. Owing to COVID-19, participants were assessed through either in-person visits or telephone questionnaires. The primary outcome was the incidence of permanent suture or mesh exposure. Secondary outcomes included surgical success and late adverse outcomes. RESULTS: Out of the 200 initially enrolled participants, 82 women took part in this second extension study. Among them, 46 were in the permanent suture group, and 36 in the delayed absorbable group. The mean follow-up duration was 5.3 years, with the cumulative mesh or suture exposure of 9.9%, involving 18 cases, of which 4 were incident cases. Surgical success after more than 5 years stood at 95%, with few experiencing bothersome bulge symptoms or requiring retreatment. No serious adverse events occurred, including mesh erosion into the bladder or bowel. The most common adverse events were vaginal pain, bleeding, dyspareunia, and stress urinary incontinence, with no significant differences between suture types. CONCLUSION: The study found that mesh exposure risk gradually increased over time, reaching nearly 10% after more than 5 years post-surgery, regardless of suture type. However, surgical success remained high, and no delayed serious adverse events were reported.